The organizational aspects of security support of participants of clinical testing of vaccine “Gam-COVID-Vac”

The COVID-19 pandemic resulted in many aftermaths, economic crisis and extra charging of health care. The development of vaccine against SARS-nCoV-2 agent turned out as the priority task of world and Russian medicine and pharmaceutics. The investigation of efficiency and safety of vaccines can be prolonged for many years that can aggravate the observed crisis. Having regard to the global scope and speed of pandemic spreading, the vaccine "Gam-COVID-Vac" was registered with special procedure by the Decree of the Government of the Russian Federation No. 441 of 03.04.2020 for accelerated access to civic turn-over. To monitor safety of vaccine on the basis of international experience, the decision was made to organize the independent Committee of monitoring data concerning efficacy and safety of vaccines applied to prevent COVID-19. The article presents rationale for necessity to create independent committee and to implement such a practice.